Author + information
- Received November 30, 2017
- Revision received March 21, 2018
- Accepted March 21, 2018
- Published online August 9, 2018.
- Wei Jiang, MDa,b,∗ (, )
- David J. Whellan, MDc,
- Kirkwood F. Adams, MDd,
- Michael A. Babyak, PhDb,
- Stephen H. Boyle, PhDb,
- Jennifer L. Wilson, BAb,
- Chetan B. Patel, MDa,
- Joseph G. Rogers, MDa,
- William S. Harris, PhDe and
- Christopher M. O’Connor, MDf
- aDivision of Cardiology, Department of Medicine, Duke University, Duke University Medical Center, Durham, North Carolina
- bDivision of Psychiatry and Behavioral Sciences, Department of Medicine, Duke University, Duke University Medical Center, Durham, North Carolina
- cDepartment of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania
- dDivision of Cardiology, Department of Medicine and Radiology, University of North Carolina at Chapel Hill Medicine, Chapel Hill, North Carolina
- eDepartment of Medicine in the Sanford School of Medicine, University of South Dakota, Vermillion, South Dakota, and OmegaQuant, Sioux Falls, South Dakota
- fInova Heart & Vascular Institute, Falls Church, Virginia
- ↵∗Address for correspondence:
Dr. Wei Jiang, Division of Cardiology, Department of Medicine, Duke University, Duke University Medical Center, DUMC Box 3366, Durham, North Carolina 27710.
Objectives The goal of this study was to test the effects of long-chain omega-3 fatty acid supplementation on omega-3 levels, depressive symptoms, and other psychosocial factors, as well as other chronic heart failure (CHF)-related functional measures.
Background Patients with CHF and depression had low blood omega-3 concentrations that were associated with an elevated risk of mortality.
Methods This study was a randomized, double-blind, placebo-controlled pilot clinical trial using a 400/200 eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) fish oil at 2 g and an almost pure EPA at 2 g, compared with a matched placebo, daily for 12 weeks for patients with CHF and major depressive disorder. Statistical analyses included the intention-to-treat population and “completers” (defined as participants consuming ≥70% of the capsules and completing the final endpoint evaluation between 10 and 14 weeks).
Results A total of 108 patients with CHF and major depressive disorder and a score ≥18 on the Hamilton Depression Scale who were randomized at 1:1:1 to the 3 interventions at 3 enrolling centers from June 12, 2014, to May 19, 2016; 80 (74.1%) qualified as completers. Intention-to-treat analyses revealed that the levels of all omega-3 variables were significantly elevated in the omega-3 groups, whereas the placebo group showed little change; there were no between-group differences with overall depression measurements. Per-protocol exploratory analyses showed that scores on the social functioning measurement of the 36-item Short Form Health Survey improved notably in the 400/200 EPA/DHA (p = 0.040) and EPA (p = 0.10) groups compared with the placebo group. Spearman correlation analysis indicated that increased omega-3 indices were associated with improved cognitive depressive symptoms.
Conclusions Omega-3 supplementation resulted in significant increases in omega-3 levels in red blood cell counts, corresponding to a particular compound of omega-3. Changes in cognitive depressive symptoms and social function were in favor of the omega-3 supplementation. Further studies with larger sample sizes are necessary to confirm the benefits of omega-3 supplementation on modifying psychosocial factors for patients with CHF. (Omega-3 Supplementation for Co-Morbid Depression and Heart Failure Treatment [OCEAN]; NCT02057406)
This study was supported by the National Institute of Mental Health collaborative R34 mechanism (NIMH 1R34MH097034). The sponsors of this study played no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, and approval of the manuscript. Dr. Harris is the owner of OmegaQuant Analytics, LLC, which performed the omega-3 assays for this study free of charge. Dr. O’Connor has received funding from Actelion Pharmaceuticals Ltd., Amgen Inc., Biscardia LLC, Faculty Connection, GE Healthcare, Ikaria, Novella Clinical Inc., Pfizer Inc., Pozen, and Roche Diagnostics; serves as a consultant for Novartis, HeartWare, ResMed, Johnson & Johnson, Gilead, Critical Diagnostics, BG Medicine, Otsuka, Astellas, Cytokinetics, and Capricor; and holds stock or stock options in Neurotronik/Interventional Autonomics Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Barry Greenberg, MD, served as Guest Editor for this paper.
- Received November 30, 2017.
- Revision received March 21, 2018.
- Accepted March 21, 2018.
- 2018 American College of Cardiology Foundation
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